- Merck (Rahway, NJ)
- …Extensive knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- J&J Family of Companies (Titusville, NJ)
- …Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance , clinical supplies ... the clinical team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol development, execution of… more
- Universal Technical Resource Services, Inc. (Marlton, NJ)
- …customers on time and within budget. This position, Fighter Military Flight Operations Quality Assurance (MFOQA) Flight Data Analyst ( FDA ), works with the Air ... across the ACC Fighter MFOQA fleet (F-16, F15 variants). Additionally, the Fighter FDA enhances flight safety through the management and analysis of data collected… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …bring new and modified medical devices to market and ensure ongoing compliance . They participate on cross-functional teams, lead the development of global regulatory ... in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other regulatory documents for submission to… more
- System One (Florham Park, NJ)
- …in development (including 2 new IND applications and 1 NDA) + Knowledge of and Compliance with FDA , EMEA, PMDA guidances + Performance will be monitored via ... + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines. + Excellent communication and interpersonal… more
- System One (Princeton, NJ)
- …development of FDA regulated products + Assist in maintaining laboratory compliance including equipment maintenance Requirements + BS or MS degree from an ... draw conclusions, and recommend actions + Basic knowledge of FDA regulatory requirements for OTC products + Ability to...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Bristol Myers Squibb (Princeton, NJ)
- …operational excellence for regulated bioanalytical studies and CDx development, ensuring high quality , compliance , and timely delivery of internal and outsourced ... liaison with CROs and external partners, managing study milestones, deliverables, and compliance with BMS quality systems and regulatory standards. **… more
- Bayer (NJ)
- …meetings including program evaluation, required attendance and coordination of high quality meeting reports; + Identifies educational gaps and provides subsequent ... Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and… more
- Bristol Myers Squibb (Princeton, NJ)
- …risk management and compliance with local and international PV regulations (eg, FDA , EMA, ICH). + Oversee safety operations team members and vendors in managing ... benefit-risk profiles. The ED works cross-functionally with clinical, regulatory, medical affairs, quality , and commercial teams to support the safe use of products… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the...projects, to meet plans and to deliver the expected quality on time and on budget. - Based on… more